Biomarker & Bioanalytics Lead

COMPANY

Octant is a well-backed team of experienced scientists and entrepreneurs at the frontiers of biology, chemistry, and computation. We are a small molecule therapeutics company combining high-throughput synthetic biology, generative chemistry, and AI/ML to repeatedly develop precision medicines for genetically defined diseases.

JOB DESCRIPTION

Octant is seeking a Lead for a new function – Clinical Biomarkers & Bioanalytics – to play a pivotal role in advancing our small molecule drug pipeline. This position is crucial for supporting our clinical research and development activities across our rare disease small-molecule corrector pipeline. The candidate will be responsible for defining and executing biomarker strategies in our clinical trials, including the design, qualification and validation of novel biomarker approaches.

Octant is dedicated to addressing significant unmet needs in rare diseases, with a pipeline that is currently focused on Rhodopsin-associated autosomal dominant Retinitis Pigmentosa (RHO-adRP) and Fabry Disease. The role will be require oversight and excellence across a broad range of Clinical biomarker and bioanalytical assays, including pharmacokinetics (PK), imaging studies, assessment of biopsy data, whole blood assays, and mass spectrometry-based assessment of plasma, cellular and tissue biomarkers.

Key Responsibilities:

• Strategic Leadership: Develop, supervise and execute comprehensive biomarker strategies to support clinical development, including pharmacodynamic and predictive biomarkers, patient stratification, and response monitoring.
• Assay Development and Validation: Oversee the development, outsourcing, and validation of clinically applicable biomarker assays. Design, implement, and manage biomarker testing and data analysis to ensure robust and reproducible results.
• Regulatory Engagement: Lead Biomarker & Bioanalytics Strategy and provide input on clinical protocols, IND applications, and other regulatory submissions. Participate in meetings with regulatory authorities to advocate for biomarker-driven clinical development plans.
• External Collaborations: Identify, establish, and oversee collaborations with key opinion leaders, academic sites, and CROs to advance our understanding of disease pathways and prognostic/predictive biomarkers.
• Technical Expertise: Guide the development and validation/qualification of imaging and Mass Spec assays for pharmacokinetic (PK), toxicokinetic (TK), pharmacodynamics (PD) and biomarker quantification in various biological matrices. Develop ex vivo assays to determine biological activity across diverse tissue samples.
• Data Analysis and Interpretation: Conduct detailed review and analysis of biomarker study data, ensuring rigorous scientific validity and compliance with regulatory standards.
• Team Leadership: Lead a multidisciplinary team of scientists and research associates. Foster a collaborative and innovative culture that drives scientific excellence and operational efficiency.
• Scientific Communication: Present findings to internal teams, scientific conferences, and contribute to peer-reviewed publications. Prepare regulatory documents for presentation to FDA and global regulatory agencies. Stay abreast of the latest scientific advances and regulatory guidelines in relevant disease areas and pharmacology.

THIS JOB MIGHT BE GREAT FOR YOU IF YOU HAVE:

• Educational Background: Ph.D. or M.D. in Pharmacology, Biomedical Sciences, or a related field. Additional leadership experience and on the job training can substitute for formal degree programs. 
• Experience: Minimum of 10 years of post-graduate experience, including at least 5 years in the biotechnology or pharmaceutical industry.
• Technical Competency: Proven expertise in biomarker assay development, including LC-MS/LC-MS-MS, and ex vivo assays for biological activity determination. Familiarity with ophthalmological imaging systems preferred. 
• Regulatory Knowledge: Extensive experience in preparing and reviewing regulatory documents, with specific experience in IND and CTA submissions.
• Collaboration and Management: Demonstrated ability to manage relationships with internal stakeholders, CROs and external collaborators effectively. Proven leadership in managing multidisciplinary teams.
• Communication Skills: Excellent analytical, organizational, and communication skills. Ability to present complex scientific data to diverse audiences.
• People Management: Proven track r